MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number	221270
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd bbl¿ macconkey ii agar was contaminated, and noticed some plates were already growing an organism.And some plates grew the organism after incubation.Patients were treated based on erroneous results.It is unclear what the treatment was and the adverse affect of the treatment.
Additional Manufacturer Narrative
Investigation summary: during manufacturing of material: 221270, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The complaint history was reviewed, and no other complaints have been taken on batch: 3254396.No retention samples for this batch were available for investigation.No return samples were received for investigation of this complaint.Six photos were received for investigation of this complaint.Photos show contamination in batch: 3254396 with timestamp 0959 visible in one of the photos.This complaint can be confirmed.No complaint trends have been identified on this product for this defect.Bd will continue to trend complaints for contamination.
Event or Problem Description
It was reported when using the bd bbl¿ macconkey ii agar was contaminated, and noticed some plates were already growing an organism.And some plates grew the organism after incubation.Patients were treated based on erroneous results.It is unclear what the treatment was and the adverse affect of the treatment.

• Brand Name: BD BBL¿ MACCONKEY II AGAR
• Common Device Name: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18383643
• Report Number: 1119779-2023-01411
• Device Sequence Number: 4133405
• Product Code: JSI
• UDI-Device Identifier: 00382902212706
• UDI-Public: (01)00382902212706
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/21/2023
• Device Catalogue Number: 221270
• Device Lot Number: 3254396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown